Intravenous Cannulation In Children During Sevoflurane Induction
17 de agosto de 2017 actualizado por: Leila mansali stambouli
Intravenous Cannulation In Children During Sevoflurane Induction: Which Time is Adequate
This interventional simple-blind,randomized trial has included 90 children of American Society of Anesthesiologist (ASA) physical status I or II aged between 1 to 12 years of either sex, scheduled for for outpatient minor surgery under general anesthesia.
This study examined whether one should make iv attempts during the early induction period (at 60 seconds) or lately (90 or 120 s) and waiting until the child receives additional sevoflurane inhalation anesthesia.
Descripción general del estudio
Estado
Terminado
Condiciones
Descripción detallada
We conducted a prospective randomized study, after obtaining Institutional review board approval, which didn't require written parental consent.
Children age 1-12 years, undergoing elective general anesthesia via an inhalation induction were randomized to one of three groups of 30 patients each one, for iv placement, either 60s (group E), 90 or 120 s (group L) following loss of lid reflex.
Movement on iv placement and incidence of laryngospasm were determined.
Difficulty with iv placement was also recorded.
Statistical analysis included contingency testing, ANOVA, and non parametric testing.
A P-value <0.05 was considered significant.
Tipo de estudio
Intervencionista
Inscripción (Actual)
90
Fase
- No aplica
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
1 año a 12 años (Niño)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- children with American Society of Anesthesiologist (ASA) physical status I or II
- age between 1 and 12 years of either sex,
- were scheduled for outpatient minor surgery under general anesthesia
Exclusion Criteria:
- age <1 and >12 years
- patients with full stomach
- a history of gastric reflux
- history of convulsions, cardiovascular or neuromuscular disease
- suspected difficult airway and hyper-reactive airway disease
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Otro: 60s (group E)
The Time of catheterization at 60s (group E) was applied in this study group,after sevoflurane inhalation induction, 30 children have a catheterization after a time of 60 seconds following the eye closure and the loss of lid reflex.Difficulty with intravenous catheterization, limb movement and laryngospasm were recorded.Difficulty of catheterization in group 60 s
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Otro: 90s (groupe L)
In this study group,after sevoflurane inhalation induction, 30 children have a catheterization after a time of 90 seconds following the eye closure and the loss of lid reflex.Difficulty with intravenous catheterization, limb movement and laryngospasm were recorded.Difficulty of catheterization in group 90 s
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Otro: 120s (groupe L)
In this study group,after sevoflurane inhalation induction, 30 children have a catheterization after a time of 120 seconds following the eye closure and the loss of lid reflex.Difficulty with intravenous catheterization, limb movement and laryngospasm were recorded.Difficulty of catheterization in group 120 s
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Success of intravenous insertion
Periodo de tiempo: from the end of study period of time after the loss of eyelash reflex to successful cannulation less than 30 seconds
|
success insertion of intravenous cannula was achieved at the first attempt less than 30 seconds
|
from the end of study period of time after the loss of eyelash reflex to successful cannulation less than 30 seconds
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
limb movement
Periodo de tiempo: from the end of study period of time after the loss of eyelash reflex to successful cannulation less than 30 seconds
|
The movement was classified using the scale: (0 No movement, 1 movement) The incidence of laryngospasm was defined as the sudden complete or partial loss of air exchange with concurrent loss of a capnographic wave. The movement was classified using the scale: (0 No movement, 1 movement) The incidence of laryngospasm was defined as the sudden complete or partial loss of air exchange with concurrent loss of a capnographic wave. • The movement was classified using the scale: (0 No movement, 1 movement) • The movement was classified using the scale: (0 No movement, 1 movement) The limb movement was classified using the scale:0 No movement, 1 movement) |
from the end of study period of time after the loss of eyelash reflex to successful cannulation less than 30 seconds
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
laryngospasm
Periodo de tiempo: from the end of study period of time after the loss of eyelash reflex to successful cannulation less than 30 seconds
|
laryngospasm was defined as the sudden complete or partial loss of air exchange with concurrent loss of a capnographic wave.
|
from the end of study period of time after the loss of eyelash reflex to successful cannulation less than 30 seconds
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: leila Mansali Stambouli, MD PhD, University Hospital of Fattouma Bourguiba Monastir TUNISIA
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Schwartz D, Connelly NR, Gutta S, Freeman K, Gibson C. Early intravenous cannulation in children during sevoflurane induction. Paediatr Anaesth. 2004 Oct;14(10):820-4. doi: 10.1111/j.1460-9592.2004.01315.x.
- Choudhry DK, Stayer SA, Schwartz RE, Pasquariello CA. Early intravenous cannulation in children during inhalational induction of anaesthesia. Paediatr Anaesth. 1998;8(2):123-6. doi: 10.1046/j.1460-9592.1998.00731.x.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
1 de agosto de 2016
Finalización primaria (Actual)
31 de octubre de 2016
Finalización del estudio (Actual)
31 de octubre de 2016
Fechas de registro del estudio
Enviado por primera vez
11 de agosto de 2017
Primero enviado que cumplió con los criterios de control de calidad
17 de agosto de 2017
Publicado por primera vez (Actual)
18 de agosto de 2017
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
18 de agosto de 2017
Última actualización enviada que cumplió con los criterios de control de calidad
17 de agosto de 2017
Última verificación
1 de agosto de 2017
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- OMB: 0925-0586
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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